ADA Analyst Presentation Saturday 9 th June

Transcription

1 ADA Analyst Presentation Saturday 9 th June Carlo Russo Senior Vice-President & Albiglutide Team Leader, GSK Property of GlaxoSmithKline

2 Agenda Welcome & introduction to the Harmony Clinical Programme Results from Harmony 6 & Harmony 7 The Evolution of Type 2 Diabetes Treatment Carlo Russo Senior Vice-President, Albiglutide Team Leader Dr Richard E. Pratley Director, Florida Hospital Diabetes Institute, USA Professor Philip Home Professor of Diabetes Medicine, Newcastle University, UK Q&A discussion Refreshments

3 The HARMONY Programme: Ongoing Phase III Studies Study Background Therapy Comparators No. of Patients Randomized Primary Endpoint Estimated LPLV H2H vs liraglutide HARMONY 7 Metformin, pioglitazone, glimepiride, or combination Liraglutide weeks COMPLETED Presented at ADA 2012 Add-on to insulin glargine HARMONY 6 Basal insulin glargine Prandial insulin months COMPLETED Presented at ADA 2012 Renal impairment HARMONY 8 Monotherapy HARMONY 2 Metformin, pioglitazone, glimepiride, or combination Diet & exercise (treatmentnaïve patients) Sitagliptin months Jul 2012 Placebo year Jan 2013 Add-on to pioglitazone HARMONY 1 Add-on to metformin + SU HARMONY 5 Pioglitazone ± metformin Placebo year Jan 2013 Metformin + glimepiride Pioglitazone or placebo year Mar 2013 H2H vs insulin glargine HARMONY 4 Metformin or metformin + SU Insulin glargine year Feb 2013 Add-on to metformin HARMONY 3 Metformin Sitagliptin, glimepiride, or placebo years Feb 2013

4 Harmony 6 Results Add-on to Insulin Glargine vs prandial Lispro Insulin in Subjects With Type 2 Diabetes Mellitus Richard Pratley MD Director, Florida Hospital Diabetes Institute & Diabetes Professor, Sanford Burnham Medical Research Institute, Florida, US

5 Harmony 6 Study Design Insulin glargine 20 units per day N = 500 HbA1c: % Albiglutide mg weekly n = 250 Prandial lispro N = 250 Primary Endpoints: Non-inferiority vs lispro Superiority vs lispro, if noninferiority met Other Endpoints: Time to, and % requiring Weight Hypoglycemia QoL FP rescue Study Design Randomized, open-label active controlled, parallel group study Optional up-titration of albiglutide mg weekly, starting at Week 8 Titration of basal and pre-prandial insulin, to meet pre-specified protocol criteria Primary Endpoint: 26 weeks Study Duration: 52 weeks 586 randomized; 566 received treatment

6 Overall Conclusions Efficacy Both albiglutide and lispro produced clinically significant reductions in HbA1c from baseline (-0.82 % vs -0.66%, respectively) Albiglutide met the non-inferiority endpoint for HbA1c vs. lispro (p<0.0001) at 26 weeks, and only just missed showing superiority (p=0.0533) The FPG trend mirrored the HbA1c curve, with greater reduction in the albiglutide treatment arm than the pre-prandial Lispro arm The observed weight change at Week 26 in the albiglutide arm was statistically greater than the pre-prandial insulin arm (-0.73 kg vs kg) No meaningful difference between treatment groups when viewed by subgroup (background OAD, gender, race, etc) Efficacy and weight loss in the albiglutide arm were maintained through 52 weeks

7 Overall Conclusions Safety The 52 week nausea/vomiting rates for albiglutide were consistent with Harmony 7. Rates were higher in the albiglutide arm compared to Lispro: Nausea: 13.0% with albiglutide and 2.1% with Lispro Vomiting: 7.0% with albiglutide and 1.4% with Lispro Hypoglycemia at week 52: 32.6% with albiglutide and 49.8% with Lispro Three events of severe hypoglycemia in the pre-prandial Lispro arm vs zero in the albiglutide arm Rates of events of special interest at Week 52 with albiglutide were consistent between this study and Harmony 7: Injection site reactions: 9.5% with albiglutide and 5.3% with Lispro Acute pancreatitis: Zero events with both albiglutide and Lispro Thyroid nodules/neoplasm: one subject who received one dose of albiglutide with calcitonin elevated at baseline & subsequently determined to be MEN positive, and no subjects with Lispro

8 Harmony 7 Results A Randomized, Open-Label, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of Albiglutide as Compared With Liraglutide in Subjects With Type 2 Diabetes Mellitus

9 Harmony 7 Study Design Inadequate control on Met, TZD, SU, or combination N = 800 HbA 1c : 7%-10% Albiglutide n = 400 Liraglutide n = 400 Primary endpoints Noninferiority ( superiority) vs liraglutide Other endpoints FPG Time to rescue Weight Hypoglycemia QoL Study Design Randomized, double-blind, active-controlled, parallel-group study Titration protocol of albiglutide mg QW and liraglutide ( mg QD) Study duration: 32 weeks Primary endpoint: Change in HbA 1c from baseline as compared with liraglutide

10 Overall conclusions Liraglutide (once daily) and albiglutide (once weekly) clinically and statistically reduced HbA1c from baseline. ( 0.78% 0.99 with ALBI and 0.99% 1.02 with LIRA [treatment difference: 0.21% P <.001]) The treatment difference did not meet non-inferiority criteria. (95% CI: %). Albiglutide was generally well tolerated and had a better GI tolerability than liraglutide Both agents showed reductions in weight loss, but this was better with liraglutide (LIRA [ 2.19 kg] greater than ALBI [ 0.64 kg])

11 Type II diabetes: An evolving treatment landscape Professor Philip Home Professor of Diabetes Medicine, Newcastle University, UK

12 Q&A